Pharmacokinetics and Pharmacdynamics of Sildenafil

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To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension. [ Time Frame: Multiple time points throughout the study ]

Original Secondary Outcome Measures

Same as current

Current Other Outcome Measures

Not Provided

Original Other Outcome Measures

Not Provided

Descriptive Information

Brief Title

Pharmacokinetics and Pharmacdynamics of Sildenafil

Official Title

The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients

Brief Summary

The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.

Detailed Description

There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.

Study Type

Observational

Study Design

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Blood specimens

Sampling Method

Non-Probability Sample

Study Population

Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension.

Condition

Pulmonary Hypertension

Intervention

Procedure: Obtain blood specimens

Obtain blood samples at multiple timepoints.

Study Groups/Cohorts

A

Patients receiving sildenafil as standard of care

Intervention: Procedure: Obtain blood specimens

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.